Solid Biosciences Inc. SLDB announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its novel AAV-based gene therapy candidate, SGT-212, for the ...

Humacyte (HUMA) announced that it plans to file an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, ...

Plans for filing an IND was agreed with the FDA in a recent meeting –– Positive preclinical results of the small-diameter ATEV were recently ...

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...

has approved Alphamab Oncology’s investigational new drug application (IND) for the multicentre Phase I/II JSKN033-102 trial of JSKN033. The therapy is a high-concentration subcutaneous co-formulation ...

The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...

The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...

Revidia Therapeutics Inc., a cardiac regenerative medicine company developing first-in-class small molecule drug therapies for heart injury, has announced that it has expanded its leadership team in ...

The company has also filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for NUZ-001, a pivotal step toward initiating a Phase 2/3 clinical trial under ...

INCHEON, South Korea, Jan. 15, 2025 /PRNewswire/ — Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, ...

The last decade has seen a “dramatic increase” in investigational new drug (IND ... To date, the FDA has not approved any marketing drug application for cannabis for the treatment of any ...